Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Comparison

Официальное название

Robotic Surgery in the Treatment of Deep Endometriosis: Da Vinci Vs HUGO RAS Compared

Обзор

The aim is to clarify whether both surgical approaches represent, equivalently, a good treatment for the management of patients with deep endometriosis who are candidates for surgery, or whether there are any differences between the two methods, and, if so, how they differ

Подробное описание

Numerous studies have shown how surgical excision of deep endometriosis nodules improves pain and quality of life. Robotic-assisted laparoscopic surgery has been employed for the treatment of deep endometriosis. While the Da Vinci System is widely used for the surgical treatment of endometriosis, with good results, the available data regarding the benefits of the HUGO RAS System, however, are limited, given the recent introduction of this method in gynecology, and particularly in the treatment of endometriosis. The aim of the study is to investigate whether the robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis

Первичные конечные точки

• The robotic surgical approach using HUGO RAS is noninferior to that performed using Da Vinci in terms of operative time (docking + surgical time) in the surgical treatment of patients with endometriosis [Срок оценки: During surgery]

Вторичные конечные точки (8)

• Conversion rate to laparoscopy or laparotomy [Срок оценки: During surgery]
• Intra-operative and post-operative complication rates; need for complication treatment [Срок оценки: Perioperative and at 3 months]
• Ergonomics for the surgeon [Срок оценки: During surgery]
• Entity of postoperative pain [Срок оценки: Perioperative and at 3 and 12 months]
• Hospitalization time [Срок оценки: From the day of admission to the day of discharge, an average of 1 year]
• Assessment of pain and quality of life [Срок оценки: At 3 and 12 months after surgery]
• Assessment of pain and quality of life [Срок оценки: At 3 and 12 months after surgery]
• Symptomatological and/or anatomical recurrence [Срок оценки: At 12 months after surgery]

Критерии участия

Критерии включения

• Age between 18 and 55 years;
• Pelvic ultrasound and/or radiologic (MRI/CT scan with rectal insufflation) diagnosis of endometriosis
• Indication for surgery (symptomatic despite or refractory to medical therapy, and/or with critical bowel stenosis or urinary stenosis, and/or infertile awaiting medically assisted procreation (PMA) treatment or with previous failed assisted fertilization attempts);
• ASA (American Society of Anesthesiologists physical status classification) class between 1 and 3;
• Acquisition of consent to undergo surgical treatment;
• Acquisition of consent for study participation and data processing

Критерии исключения

\- Past or current diagnosis of gynecologic oncologic pathology.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
• Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuor — Roma

Идентификаторы

NCT: NCT06781398 · ROBOTENDO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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